Figure 3.3 shows the effect of changing the 'diagnostic cut-off value' on test specificity and sensitivity
Normal is no disease present
Analytical variation is generally less than that from biological variation
Biochemical test results are usually compared to a reference interval chosen arbitrarily to include 95% of the values found in healthy volunteers
This means that, by definition, 5% of any population will have a result outside the reference interval
In some situations it is useful to define 'action limits', at which appropriate intervention
There is often a degree of overlap between the disease state and the 'normal value'
An abnormal result in a patient who is subsequently found not to have the disease is called a 'false positive'
A 'normal result' in a patient who has the disease is a 'false negative'